Methods and systems for breast reconstruction

ABSTRACT

Methods for optimal breast reconstruction are disclosed. The methods include steps for performing a mastectomy that preserves a breast skin envelope. A prosthesis may be inserted into the breast and may be inflated to preserve the shape of the breast skin envelope. The prosthesis may include, a base, a balloon coupled to the base, where the balloon may be inflated to preserve the shape of the breast skin envelope. The prosthesis may also include tube coupled to port for filling the balloon to a predetermined volume. A needle-lock system, coupled to the port may be used to inject, for example, fluids into the balloon. If a patient requires post-mastectomy radiation, breast reconstruction may be delayed and the prosthesis may remain in the breast cavity during the treatment. The treatment may be external beam radiation. Alternatively, the treatment may include brachytherapy technique for treating the internal breast cavity.

This application is a continuation of U.S. patent application Ser. No.12/063,403 filed Jul. 9, 2008, entitled “Method and Systems For BreastReconstruction”, which is a U.S. National Stage under 35 U.S.C. §371 ofInternational Patent Application No. PCT/US2006/031091 filed Aug. 9,2006, which claims priority to U.S. Provisional Patent Application No.60/706,543 filed Aug. 9, 2005, and U.S. Provisional Patent ApplicationNo. 60/737,657 filed Nov. 17, 2005.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH DEVELOPMENT

Not applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to breast reconstruction, moreparticularly, to techniques for preserving the breast skin envelope forbreast reconstruction.

2. Description of Related Art

For breast cancer patients who undergo mastectomies and desire breastreconstruction, reconstructive surgery generally occurs soon after themastectomy, if not immediately after the mastectomy, to permit the bestaesthetic outcomes. For patients with early-stage breast cancer, eitherstage 1 or stage 2 breast cancer, immediate reconstruction is feasiblebecause these patients do not generally require post-operative radiationtherapy. However, if the need for post-mastectomy treatment arises afterthe breast is reconstructed, the patient may be at an increased risk forcomplications, such as adverse aesthetic results and inhomogeneousradiation delivery. For example, as noted in many trials, survivaladvantages with post-mastectomy treatment occur when the internalmammary nodes are included within the radiation fields. To treat theseinternal mammary nodes while minimizing the dose to the heart and lungs,a separate electron beam on the medial chest wall is required to matchthe laterally placed opposed tangent fields. However, the slopingcontour of a reconstructed breast leads to an imprecise geometricmatching of the fields, and thus results in either exclusion oftreatment to the internal mammary nodes and/or increased radiation ofnormal tissues. Additionally, the radiation may increase the chances ofcapsular contracture with an implant-based reconstruction, which candistort the appearance of the reconstructed breast and cause chronicchest wall pain and tightness among other issues. Autologous tissue canalso be adversely affected by radiation treatments resulting in thenecrosis of tissue that can result in complications and asymmetry withthe constructed breast. Any surgical revisions to a radiated breastreconstruction can be unpredictable and cause multiple complications, aswell as require multiple steps.

In recent trials, such as Danish and Vancouver Trials, results show thatfor patients with early-stage breast cancer, post-mastectomy radiationtherapy in addition to chemotherapy reduces the rate of locoregionalrecurrences and increases survival rates. Unfortunately, the need forpost-mastectomy radiation therapy cannot be reliably determined at thetime of a mastectomy. Pathology analysis of the mastectomy specimen andnodal tissue on permanent sections removed during a mastectomy isperformed before a decision of whether a patient needs post-operativetreatments can be made, with results taking upwards of a week to return.This delay may cause reconstruction to be pushed back, affectingaesthetic outcomes for reconstruction. For example, for standard delayedreconstruction, if the breast skin is not completely removed, anyremaining skin may be undesirable because the skin malleability orelasticity deteriorates during the waiting period and/or during anypost-operative therapy. Any subsequent reconstruction will be less thandesirable, causing physical, emotional, and physiological distress tothe patient.

Currently, different devices are being used to prepare the breast areafor a permanent implant. One example is a tissue expander, whichtypically includes a bladder or envelope that will hold a liquid such assaline. The tissue expander can be used to stretch any skin remainingfrom the mastectomy to a larger dimension, particularly to a dimensionthat can accommodate the breast implant. In order to stretch the skin,after the mastectomy, the tissue expander is implanted under tissue,such as under the muscles below a surgically removed breast. Prior tothe placement of the permanent breast implant, a small amount of salineis added to the envelope periodically until a desired size is reached.Typically, by adding the liquid slowly over a period of weeks or months,the covering tissue is allowed to expand to accommodate the liquid.Alternatively, the bladder may be completely filled intraoperatively.

One problem with using tissue expanders after a mastectomy is thestretching of the tissue and/or the skin. Due to the removal of mosttissue and/or skin in the breast area during the mastectomy, anyremaining tissue and/or the skin can be stretched thin enough thatdamages such as tearing or protrusion of the tissue expander and/or animplant through the skin can occur. The surface, therefore, becomes toodelicate and hard to work with during reconstruction.

If pathology results show that a patient requires post-mastectomyradiation therapy and/or chemotherapy, the tissue expanders may need tobe removed to optimize treatment. For example, among other issues, ifthe inflated tissue expander remains on the chest wall, the tissueexpander may deflect radiation beams, causing an inhomogeneous radiationfield that exposes areas not needing therapy or not treating the regionsthat require treatment. Also, the tissue expander may be damaged due tothe radiation beam, and thus may leak or otherwise lead to undesirableresults. Subsequently, the tissue expander may need to be removed inorder to proceed with post-mastectomy therapy (i.e., radiation therapy).

Alternatively, if a patient requires post-mastectomy radiation therapy,the liquid in the tissue expander may be removed prior to the treatment.This method cuts down the recovery time for the patient and may avoiddelays in the start of post-mastectomy therapies. Generally, to deflatethe tissue expander, a needle is inserted into a metal port integratedinto the envelope of the tissue expander to draw out the liquid.However, there are complications caused by the metal port used to filland drain the envelope. If a patient requires post-mastectomy radiationtherapy and the tissue expander remains in the patient, the metal portcan deflect the radiation beam, resulting in an inhomogeneous radiationfield. Areas not needing radiation therapy may be exposed and can causemore harm to the patient, and areas needing treatment may not receivethe radiation.

Another problem associated with current tissue expanders is when theyare deflated, the bladder of the tissue expander curls in at the edges,creating a cupped profile. These cupped edges can deflect radiationbeams. These edges may also cause pressure to the overlying skin andcause the skin to become irritated and/or cause the tissue expander tobecome exposed or protrude through the skin. Further, the backwardpressure created by the expansion can push against the chest wall,creating a concave deformity on the surface on the chest wall. This canresult in discomfort to the patient, including, but not limited to, painand breathing problems. Upon reconstruction, the concave nature of thechest wall can create aesthetic problems, e.g., requiring more tissue tofill the space. This problem may create an unnatural breast shape andasymmetry with the contralateral breast.

Other problems associated with current tissue expanders include thedeficiencies of removing fluids that collect at the expander afterremoval of the surgical drain, such as, for example, seroma fluidscollecting at or around the breast region. Generally, patients would berequired to undergo needle drainage and the use of an external catheter.The insertion of the needle may require radiographic imaging to avoidinadvertent puncturing of the expander. Additionally, the long-term useof the drainage catheter may cause a great risk of infection to thepatient. As such, the inadvertent collection of peri-expander fluid inthe breast and axillary area can be costly, cause significantcomplications, and can be inconvenient for the patient.

Any shortcoming mentioned above is not intended to be exhaustive, butrather is among many that tends to impair the effectiveness ofpreviously known techniques for breast reconstruction; however,shortcomings mentioned here are sufficient to demonstrate that themethodologies appearing in the art have not been satisfactory and that asignificant need exists for the techniques described and claimed in thisdisclosure.

SUMMARY OF THE INVENTION

The present disclosure provides methods and apparatuses for optimizingbreast reconstruction for breast cancer patients or patients who undergopreventive mastectomies. The present disclosure provides a prosthesisthat can be used to preserve the breast skin envelope and naturallandmarks of the breast during a time period between the mastectomy andthe definitive breast reconstruction for determining if anypost-mastectomy therapy treatment is needed. Alternatively, the presentdisclosure provides a prosthesis that can be used to preserve the breastskin envelope and natural landmarks of the breast during a time periodbetween the mastectomy and the definitive breast reconstruction for apatient to recovery from the mastectomy.

Additionally, the present disclosure provides methods and apparatusesthat can optimize radiation treatments for patients who requirepost-mastectomy radiation therapy. In one embodiment, the prosthesisdisclosed can remain in the breast cavity during conventional externalbeam radiation techniques. Alternatively, the prosthesis may be used toprovide internal radiation techniques.

In one respect, a method is provided. The method involves performing amastectomy on a breast and preserving a breast skin envelope. Themastectomy may be performed on patients with stage-I or stage-II breastcancer. The mastectomy may be performed on patients with stage-III orstage-IV breast cancer. Alternatively, the mastectomy may be performedon patients undergoing preventive mastectomies.

The method also includes removing a tissue sample, including, but notlimited to, breast and nodal tissues, during the mastectomy forpathology analysis. The analysis may determine if post-mastectomytherapy, such as chemotherapy or radiation therapy is needed. During theanalysis of the tissue sample, a breast skin preserver may be insertedinto the breast and inflated. The preserver may be inflated with aliquid, gas, air, radiation material including liquid radiationmaterial, soluble gases, dissolvable liquids or other radioisotopes thatmay be used for internal radiation treatment to a volume for preservingthe breast skin envelope until at least the final results of thepathology reports are known.

In some respects, the preserver may include: a base structure configuredto collapse during the inflation of the preserver, a balloon coupled tothe base, where the balloon is inflated to a volume for preserving thebreast skin envelope, an instillation/evacuation tube coupled to theballoon for inflating the balloon, and an instillation/evacuation portcoupled to the instillation/evacuation tube In one embodiment, a needlelocking system may be also be provided and may be used to access theinstillation/evacuation port externally, where the port may be locatedunderneath the skin.

Upon receiving results from the pathology analysis, the method includesa step for determining a time for breast reconstruction based on thepathology analysis. In some respects, the pathology report may recommendthat a patient does not require post-mastectomy radiation treatment, andtherefore, definitive breast reconstruction may be scheduled after thepatient heals from the mastectomy surgery. In other respects, thepathology analysis may recommend the patient undergo post-mastectomytherapy, including, without limitation, chemotherapy and/or radiationtherapy. As such, the breast reconstruction may be delayed until afterthe treatment is completed.

In one respect, prior to administering the post-mastectomy therapy, thepreserver may be deflated. Alternatively, the preserver may remaininflated and a radioactive source may be provided to the preserver. Theradioactive source may include, for example, at least one brachycatheterrod that emits radiation fields (i.e., limited field radiation therapy)to treat the chest wall underlying the skin preserver and nodal basins(e.g., axillary nodal basin and the like). Alternatively, theradioactive source may be a radioactive seed, delivered by, for example,a computer through a port of the prosthesis. The seed may be deliveredto the base of the prosthesis or into an inflated or deflated balloon ofthe prosthesis.

In other respects, the step of administering the post-mastectomy therapyincludes using at least brachycatheter rod emitting radiation fieldsinternally and an external beam radiation technique to treat the skinand other nodal basin, via a radiation brassiere worn by a patient. Theprosthesis may remain inflated for this embodiment. Alternatively, theprosthesis may be deflated.

In other respects, a method including performing a mastectomy on abreast and preserving a breast skin envelope may be provided. From themastectomy, a tissue sample, including, but not limited to, breast andnodal tissues, may be removed for pathology analysis. A preserver may beinserted into the breast and inflated to a volume for preserving thebreast skin envelope as well as other landmarks of the breast.

In one embodiment, the preserver includes, among other features, a base,a balloon coupled to the base, where the balloon is inflated to thevolume for preserving the breast skin envelope, at least oneinstillation/evacuation tube coupled to the balloon forinflating/deflating the balloon, an instillation/evacuation port coupledto the instillation/evacuation tube, and a needle locking system coupledto the port. In one embodiment, the needle locking system may be used toaccess the port externally, where the port may be located underneath theskin.

Upon receiving results from the pathology, analysis requiringpost-mastectomy cancer therapy treatment, the preserver may be deflated.Alternatively, the preserver remains inflated and at least onebrachycatheter rod may be inserted into the base structure of thepreserver. The at least one brachycatheter rod can administer internalradiation to treat, for example, the chest wall and axillary nodalbasins.

In some embodiments, a combination of an external beam radiation andinternal radiation via the at least one brachycatheter rod may be used.The combination radiation treatment may treat, for example, the breastskin, the chest wall, and internal nodal basins. Alternatively, only anexternal beam radiation may be administered.

After the step of administering a post-mastectomy treatment, the patientmay undergo a breast reconstruction. Such steps including, withoutlimitation, reinflating the prosthesis if the preserver was deflated forthe treatment and removing the preserver prior to the breastreconstruction may be performed.

In other respects, a method for treating cancer in the chest area isprovided. The method includes inserting a breast skin preserver into thebreast and inflating the breast skin preserver. The preserver may beinflated to a volume for preserving the breast skin envelope until atleast the final results of the pathology reports are known. Thepreserver may also be used to treat the internal chest area. Thepreserver may include: a base structure, a balloon coupled to the base,where the balloon is inflated to the volume for preserving the breastskin envelope, an instillation/evacuation tube coupled to the balloonfor inflating the balloon, an instillation/evacuation port coupled tothe instillation/evacuation tube, and a needle locking system coupled tothe instillation/evacuation port. In one embodiment, the needle lockingsystem may be used to access the port externally, where theinstillation/evacuation port may be located underneath the skin.

The method also includes using a radiation brassiere to treat theexternal chest area. In one respect, the radiation brassiere may be usedfor patients who have undergone surgery. Alternatively, the radiationbrassiere may be used for non-surgical patients. The radiation brassieremay include a plurality of panels adapted to receive radiation rods, therods administering radiation treatment.

The term “prosthesis” or “preserver” as defined and used in thisdisclosure refers to a device that may be implanted into a patient,where the prosthesis/preserver may preserve the breast skin envelope,the breast dimensions, and other natural landmarks of the breast. In onerespect, the prosthesis or preserver may be used to maintain the breastskin envelope and natural landmarks of the breast after a mastectomy andprior to breast reconstruction surgery (with or without post-mastectomyradiation therapy). Alternatively, the prosthesis or preserver may beused for patients with partial or breast defects or no surgical breastdefects. The term prosthesis and preserver may be used interchangeablythroughout the disclosure.

The terms “a” and “an” are defined as one or more unless this disclosureexplicitly requires otherwise.

The term “substantially” or “about” and its variations are defined asbeing largely but not necessarily wholly what is specified as understoodby one of ordinary skill in the art, and in one non-limiting embodimentthe term substantially refers to ranges within 10%, preferably within5%, more preferably within 1%, and most preferably within 0.5% of whatis specified.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are openended linking verbs. As a result, a method ordevice that “comprises,” “has,” “includes” or “contains” one or moresteps or elements possesses those one or more steps or elements, but isnot limited to possessing only those one or more elements. Likewise, astep of a method or an element of a device that “comprises,” “has,”“includes” or “contains” one or more features possesses those one ormore features, but is not limited to possessing only those one or morefeatures. Furthermore, a device or structure that is configured in acertain way is configured in at least that way, but may also beconfigured in ways that are not listed.

The term “coupled,” as used herein, is defined as connected, althoughnot necessarily directly, and not necessarily mechanically.

Other features and associated advantages will become apparent withreference to the following detailed description of specific embodimentsin connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The figures are examples only. They do not limit the scope ofthe invention.

FIG. 1 is a flowchart showing steps of a method for delayed-immediatebreast reconstruction, in accordance with embodiments of thisdisclosure.

FIG. 2 is a flowchart showing steps of a method for delayed-immediatebreast reconstruction, in accordance with embodiments of thisdisclosure.

FIG. 3 is a flowchart showing steps of a method for delayed-delayedbreast reconstruction, in accordance with embodiments of thisdisclosure.

FIG. 4 is a flowchart showing steps of a method for delayed-delayedbreast reconstruction, in accordance with embodiments of thisdisclosure.

FIGS. 5A and 5B show an illustration of inflated external beamirradiation prosthesis and a brachycatheter radiation prosthesis,respectively, inserted into a breast cavity, in accordance withembodiments of this disclosure.

FIG. 6A is cross-sectional view of a deflated prosthesis, in accordancewith embodiments of this disclosure.

FIG. 6B is cross-sectional view of an inflated prosthesis, in accordancewith embodiments of this disclosure.

FIG. 6C is side profile view of an inflated prosthesis, in accordancewith embodiments of this disclosure.

FIG. 7 is cross-sectional view of an external irradiation prosthesisincluding a plurality of ports, in accordance with embodiments of thisdisclosure.

FIGS. 8A-8C show the input and output tubes of a prosthesis forinflating and deflating the prosthesis, in accordance with embodimentsof this disclosure.

FIG. 9 shows a built-in drainage system, in accordance with embodimentsof this disclosure.

FIG. 10A shows a port of a prosthesis, in accordance with embodiments ofthis disclosure.

FIG. 10B shows a plurality of needles for a needle locking system thatcan be used with the port of FIG. 10A, in accordance with embodiments ofthis disclosure.

FIG. 11A shows a 3-port and connection design, in accordance withembodiments of this disclosure.

FIG. 11B shows a 2-port and connection design, in accordance withembodiments of this disclosure.

FIG. 12 shows a port and connection, in accordance with embodiments ofthis disclosure.

FIGS. 13A and 3B show a syringe-loaded unclogger, in accordance withembodiments of this disclosure.

FIG. 14A shows a gravity drainage system, in accordance with embodimentsof this disclosure.

FIG. 14B shows a flat suction bulb drainage system, in accordance withembodiments of this disclosure.

FIG. 15 shows a battery operated vacuum drainage system, in accordancewith embodiments of this disclosure.

FIG. 16 shows a suction-tunneler device, in accordance with embodimentsof this disclosure.

FIG. 17 shows a rapid fluid filler/evacuator used to inflate/deflate theprosthesis, in accordance with embodiments of this disclosure.

FIG. 18 is cross-sectional view of a brachytherapy irradiationprosthesis including a plurality of ports, in accordance withembodiments of this disclosure.

FIG. 19A is a front view of a single unit brassiere, in accordance withembodiments of this disclosure.

FIG. 19B is a front view of a treatment zones of the brassiere of FIG.19A, in accordance with embodiments of this disclosure.

FIGS. 20A through 20D show cross-sections of a radiation brassiere, inaccordance with embodiments of this disclosure.

FIG. 21 shows a brassiere and a brachytherapy prosthesis, in accordancewith embodiments of this disclosure.

FIG. 22 shows a lateral view of a radiation brassiere, in accordancewith embodiments of this disclosure.

FIG. 23 show a technique for fitting a patient for a prosthesis and/orbrassiere, in accordance with embodiments of this disclosure.

FIG. 24 shows a method flow chart for radiation delivery, in accordancewith embodiments of this disclosure.

FIG. 25 shows a method flow chart for post mastectomy radiationtreatment, in accordance with embodiments of this disclosure.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The present disclosure provides techniques for breast reconstruction inpatients who go through at least one mastectomy due to the presence ofbreast cancer and/or patients who go through at least one preventivemastectomy due to elevated risks to develop breast cancer. By using thedisclosed prosthesis and/or radiation brassiere, which preserves theshape and form of the breast skin envelope after a skin-sparingmastectomy and which does not substantially interfere with anypost-operative therapies, patients can obtain a more natural,aesthetically pleasing outcome after breast reconstruction surgery.Additionally, the prosthesis provides for optimal radiation treatmentsfor patients requiring post-mastectomy treatments.

In particular, the present disclosure provides techniques for preservingthe breast skin and other natural landmarks of a breast after amastectomy and prior to a definitive reconstructive surgery. Between thetime of the mastectomy and reconstructive surgery, the method mayinclude a post-mastectomy treatment and/or may include time for apatient to heal from the mastectomy.

In one respect, a prosthesis, such as the external beam prosthesis orthe brachytherapy prosthesis may be inserted into a breast. Theprosthesis may be inflated up until for example, post-mastectomytreatment (e.g., external or internal radiation treatments) or until adefinitive reconstructive surgery (with or without a post-mastectomytreatment).

Additionally, the present disclosure integrates the breastreconstruction stage together with post-mastectomy radiation treatments.For example, the present disclosure provides a prosthesis that may besuitable with external beam radiation techniques (e.g., external beamprosthesis). Similarly, the present disclosure provides a prosthesisconfigured to receive a radiation source (e.g., radiation rods,radioactive seeds, radioactive liquids or gases, etc.) that may beimplanted into a patient for internal radiation treatment (e.g.,brachytherapy prosthesis). Alternatively or in addition to the abovementioned prosthesis, a radiation brassiere may be used. The radiationbrassiere may provide, amongst other things, an external radiationtreatment of the breast area for patient requiring post-mastectomytreatments.

It is noted that the one of ordinary skill in the art would recognizethat the prosthesis and radiation brassiere may be used independentlyfrom each other or in combination with one another as well with otherdevices of the present disclosure. For example, a patient may receive aprosthesis used for to preserve the breast skin envelope and otherlandmarks (delayed-immediate patients), or a prosthesis with radiationports for brachytherapy treatment may be used, or a radiation bra.Alternatively, a patient may receive a combination of the devicesincluding, for example, a prosthesis without radiation port (i.e.,external beam prosthesis) and a radiation brassiere. Further, a patientmay receive a prosthesis with radiation port(s) for internal radiationtreatment as well as receive external beam radiation (with or without aradiation brassiere).

In addition to discussing the techniques for breast reconstruction usingthe disclosed prosthesis, the present disclosure considers methods forpatients with different stages of breast cancer. In one embodiment,patients with advanced stages of breast cancer, who were generally notcandidates for breast reconstruction, may now have the option for breastreconstruction after post-mastectomy treatments. As such, in someembodiments, methods for reconstruction are provided for patients whoundergo mastectomies and are required to have post-mastectomy therapy,e.g., patients with stage-III breast cancer or stage-IV breast cancer.Therefore, the method discusses steps to prepare a field, e.g., thebreast area for a delayed reconstruction. This method is referred to asa delayed-delayed breast reconstruction in this disclosure.

In other embodiments, methods for reconstruction are provided forpatients, who undergo mastectomies and are at risk for post-mastectomytherapy, e.g., patients with stage-1 or stage-2 breast cancer. Thesepatients may not know whether they will require therapy until after themastectomy is performed and a pathology report is issued. This may bedue to the inability to identify things such as, but not limited to,micrometastases, the size of an invasive tumor in breast parenchyma, andthe like. Therefore, the methods of the present disclosure provide stepsto prepare a field, e.g., the breast area for a possible immediatebreast reconstruction after pathology reports are available. In someembodiments, the patient may require radiation therapy and as such, mayrequire reconstruction after the treatment is completed. This method isreferred to as a delayed-immediate breast reconstruction in thisdisclosure.

Similarly, for patients who undergo a mastectomy due to breast cancer inone breast and preventive mastectomy in the other, the presentdisclosure discusses methods for a more natural, aesthetically pleasingreconstruction. These patients may be a delayed-immediate breastreconstruction candidate or a delayed-delayed breast reconstructioncandidate. The process may depend on the type of breast cancer and/orthe risk level of a patient.

Delayed-Immediate Breast Reconstruction

For patients with carcinoma in-situ or early-stage breast cancer(stage-1 or stage-2 breast cancer) who undergo mastectomies, immediatereconstruction offers the best aesthetic outcome if post-mastectomyradiation is not required. If post-mastectomy therapy may be required,delaying definitive breast reconstruction can avoid aesthetic andproblems associated with radiation delivery that can occur after animmediate breast reconstruction. Generally, post-mastectomy radiationtherapy recommendations do not occur before or even during a mastectomy.Most recommendations come after a review of permanent tissue samples,which can take several weeks. As such, to optimize reconstruction, amultiple step approach may be used, such as the non-limiting exampleshown in FIGS. 1 and 2. In one embodiment, a patient may undergo askin-sparing mastectomy where the breast skin envelope is substantiallypreserved (step 102). In order for the patient to recover from themastectomy and in order to determine if a patient requirespost-operative treatment, a prosthesis may be inserted to substantiallypreserve the breast skin and landmarks of the breast. In one embodiment,a prosthesis, which may be deflated during the insertion into the breastcavity, may be filled with a liquid intraoperatively or post-operativelysuch that the 3-D shape of the breast skin envelope is maintained (step104). Particularly, the prosthesis may preserve the shape and importantlandmarks of the breast, such as, but not limited to, the inframammaryfold of the breast until definitive breast reconstruction is performed.The prosthesis is discussed in further details below.

In step 106, depending on a result of a pathology report, a patient mayor may not be required to undergo post-mastectomy radiation therapy. Forpatients that do not require post-mastectomy radiation treatment, adefinitive breast reconstruction may be performed within several weeksof the mastectomy using the preserved skin breast envelope (step 108).This time frame may avoid any delays in the start of adjuvantchemotherapy (if needed) and avoids capsule formation (e.g., an internalscar around the prosthesis) to retain the malleability of the breastskin envelope.

For patients who require radiation therapy, a series of steps, such assteps 110, 112, 114, and 116 may be performed. In one embodiment, thetime period between the mastectomy and the start of treatment allows foran internal scar (capsule formation) to form around the prosthesis priorto a possible step of deflation. The formation creates a large spacewithin the scar capsule prior to a possible step of deflation, whichallows for reinflation to occur after radiation treatment despite theassociated inflammatory effects of radiation. In some embodiments,referring to step 110, the fluid may be drained from the prosthesis,leaving a substantially deflated prosthesis, which may rest flat againstthe chest wall. The drainage of the fluids leaving may allow fortreatment of internal mammary lymph nodes without excess delivery ofradiation beams to the heart and lungs. A deflated prosthesis may alsoavoid an inhomogeneous dose distribution.

The prosthesis, which remains in the breast cavity during radiationtherapy (step 112), may maintain its structural integrity during thetherapy, and thus, may be used to prepare the breast cavity forreconstructive surgery. Additionally, the prosthesis does not interferewith the treatment, and thus, is more effective than conventionaltechniques. A more detailed description of the prosthesis is discussedbelow.

After radiation therapy is completed, the prosthesis may be reinflated(step 114). In some embodiments, reinflation occurs several weeks afterradiation therapy has completed to allow the resolution of any radiationinduced skin desquamation, which reduces the risk for infection. Thereinflation step may include gradually reinflating the prosthesis with afluid over a period of time. For example, approximately every few weeks,a small amount of air, saline or other suitable liquids may be addedinto the prosthesis, allowing for the prosthesis to regain the domain ofthe breast cavity achieved prior to deflation (step 110) and the startof radiation treatment (step 112). After the reinflation time period,the volume of the prosthesis is similar to or substantially equal to thevolume of the prosthesis during the inflation step (step 104). Once theprosthesis is reinflated, the patient may undergo definitive breastreconstruction (step 116). In one embodiment, step 116 may includeremoving the prosthesis. Once the prosthesis is removed, techniquesknown in the art including, without limitation, transverse rectusabdominis musculocutaneous (TRAM) flaps, superior gluteal arteryperforator (SGAP) flap, deep inferior epigastric perforator (DIEP) flap,latissimus dorsi (LD) flap plus implant, and the like may be used toreconstruct the breast.

Alternatively, in other embodiments, a patient who requirespost-mastectomy radiation therapy in step 106 may undergo abrachytherapy radiation process, as shown in FIG. 2. Steps 102, 104,106, and 108 are similar to those shown in FIG. 1. In step 210, withoutdeflating the prosthesis, at least one brachytherapy may beadministered. In one respect, a radiation source such as, but notlimited to, at least one radiation rod may be inserted into sleevesbuilt into the prosthesis. The radiation rod(s), positioned on the chestwall and axillary region may administer radiation emissions (step 212).In combination with the radiation rods, the radiation therapy may alsoinclude external beam irradiation to the skin and other nodal basins.Upon completion of step 212, the radiation rods may be removed, and thepatient may move ahead to other treatments or reconstruction prior tothe removal of the prosthesis and may subsequently undergo a definitivebreast reconstruction (step 214).

It is noted that other radioactive sources (e.g., seed, liquid, gaseousradioactive source) may be used in the brachytherapy radiation process.In some respect, the brachytherapy process may include more than oneradioactive source used in combination to treat the patient.

Delayed-Delayed Breast Reconstruction

Patients with stage-3 or stage4 breast cancer (large primary advancedbreast cancer or locally advanced breast cancer, LABC) generally havetreatment recommendations that include a mastectomy and apost-mastectomy radiation therapy session. Up until now, these patientswere not prime candidates of radiation delivery with breastreconstruction. This may be due to, among other issues, the problemsassociated with the conventional implants, i.e., the integrity of theimplant during the post-mastectomy radiation therapy, and/or theinability to reconstruct a natural-looking breast due to the conditionof the breast skin.

In addition, traditional mastectomy generally resects all breast skinfor stage III patients, requiring a definite, complete 3 Dreconstruction of the breast with significant autologous tissuerequirements. If a traditional expander is placed after radiationtherapy, certain complications can arise such as infection, poor woundhealing, and protrusion of the implant through the breast skin. Further,adverse radiation effects on autologous tissue reconstruction in thesepatients may affect the final aesthetic results, leading to unnaturalbreast shape and asymmetry compared to the contralateral breast. Thismay lead to, among other issues, psychological distresses to thepatient, especially since most autologous tissue can be lost and anyrevision surgery after radiation therapy resulting in a poor aestheticoutcome.

Referring to FIG. 3, a method for optimizing treatment and aestheticoutcomes from breast reconstruction for patients with stage-3 breastcancer is shown. In one embodiment, patients may undergo a skin-sparingmastectomy (step 302), post-mastectomy radiation therapy (step 308), anda definitive breast reconstruction process (step 312). The mastectomymay include, for example, a skin-preserving mastectomy that retains thebreast skin envelope.

In some embodiments, it may be necessary for a patient to undergoneoadjuvant chemotherapy session (step 301) prior to a mastectomy. Thecombination of the neoadjuvant chemotherapy, mastectomy, andpost-operative therapy may further reduce the risk of recurrence as wellas increase survival rates. Upon completion of the neoadjuvantchemotherapy, a patient may undergo a skin-sparing mastectomy, removingthe breast tissue while preserving the breast skin envelope (step 302).

After the mastectomy, a patient may be allowed time to recover from thesurgery. In some embodiments, the recovery time may be a few weeksupwards to a few months. As such, a prosthesis may be inserted into thebreast cavity at the time of the mastectomy to preserve the breast skinenvelope and other landmarks of the breast. In one embodiment, adeflated prosthesis may be inserted into the breast cavity (step 304).The prosthesis may then be inflated to a volume that preserves the 3-Dshape and landmarks of the breast. In one embodiment, the prosthesis maybe inflated in a gradual manner over time until a desired volume isachieved, i.e., post-operatively. Alternatively, the prosthesis may befilled to the desired volume in one step, i.e., intraoperatively.Embodiments of the inflation process will be discussed in more detailbelow.

When the patient is ready for radiation therapy, the prosthesis may bedeflated (step 306). In one embodiment, if a fluid was used to inflatethe prosthesis during step 304, the fluid may be drained using a portcoupled to the prosthesis. Step 306 may continue until the prosthesis iscompletely drained and lies substantially flat against the chest wall.The deflation process of the prosthesis will be discussed in more detailbelow with respect to the remote port design and the external access tothe prosthesis using a needle-locking system of the prosthesis. Upon thedeflation of the prosthesis, a radiation therapy may be administered(step 308). In one embodiment, the patient may undergo an external beamirradiation technique or other radiation techniques known in the art.

After the radiation therapy, the breast area may be prepared fordefinitive reconstruction. In one embodiment, the prosthesis may bereinflated (step 310). In one embodiment, the prosthesis may bereinflated in a gradual manner, where a small amount of fluid (e.g.,saline, water, distilled water, etc.) may be added to the prosthesisover a period of time. The prosthesis may be reinflated to a volumesimilar to or substantially equal to the volume achieved in step 304.This gradual inflation allows for the breast skin envelope to regain the3-D shape of the breast and aids the skin to adjust to the volume.

Once the prosthesis is reinflated to a desired volume, the patient mayundergo definitive breast reconstruction (312). In one embodiment, step312 includes steps for removing the prosthesis. Once the prosthesis isremoved, techniques known in the art including, without limitation,transverse rectus abdominis musculocutaneous (TRAM) flaps, superiorgluteal artery perforator (SGAP) flap, deep inferior epigastricperforator (DIEP) flap, latissimus dorsi (LD) flap plus implant, and thelike may be used to reconstruct the breast.

In some embodiments, the step of administering a radiation therapy(e.g., step 308) may include an internal irradiation process. Referringto FIG. 4, techniques for a delayed-delayed breast reconstruction isshown. steps 301, 302, and 304 are similar to the steps of FIG. 3. Afterthe patient has recovered from the mastectomy, or after theadministering of post-mastectomy chemotherapy, and/or after theprosthesis has been inflated to a desired volume to maintain the shapeand landmarks of the breast, a radioactive source, such as, but notlimited to, radiation rods may be inserted into tracks built-into theprosthesis (step 406). The at least one brachycatheter rod mayadminister radiation emissions (step 408). Upon completion of theradiation therapy, the patient may undergo definitive breastreconstruction and any intermediate steps prior to reconstruction,including, without limitation, removing the brachycatheter rod, waitingfor the patient to recover from the radiation therapy, administeringother post-mastectomy treatments such as chemotherapy, etc., as shown instep 410.

Alternatively, step 406 may include providing other radioactive sourcesto the prosthesis. For example, a radioactive seed, a radioactiveconducting wire, liquid or gaseous radiation sources may be usedseparately or in any combination for a radiation therapy. In onerespect, the radioactive sources may be provided to tracks built-intothe prosthesis. In addition to or alternatively, the radioactivesource(s) may be provided to the inflated or deflated balloon of theprosthesis.

In other embodiments, step 408 may also include an external beamirradiation in combination with the internal irradiation technique. Anexternal beam may irradiate the skin area and other nodal basins whilethe at least one brachycatheter rod integrated with the prosthesisdelivers radiation to, for example, the chest wall and axillary andinternal mammary nodal basins. Upon completion of the radiation therapy,the patient may undergo intermediate steps prior to reconstruction,including, without limitation, removing the brachycatheter rod, waitingfor the patient to recover from the radiation therapy, administering ofother post-mastectomy treatments such as chemotherapy, etc. A definitivebreast reconstruction step may follow (step 410).

Preventive Mastectomies

For patients who are at high risk for breast cancer, preventivemastectomies may reduce the chances of occurrence in the breast cavity.In some cases, a preventive mastectomy can occur at the same time abreast with abnormal cells is removed. For these patients, who may ormay not require post-mastectomy treatments, a delay in reconstructingthe breast from the preventive mastectomy such that both breasts arereconstructed at the same time may reduce the healing process andimprove the aesthetic outcome for the patient. For example, for patientswith stage-1 or stage-2 breast cancer, the determination ofpost-mastectomy treatments may take weeks to determine. As such,preserving the breast skin envelope of the breast removed from thepreventive mastectomy may be needed.

Alternatively, in other embodiments, the preventive mastectomy may beperformed at the time of a definitive reconstruction of the breastremoved due to abnormal cells. This allows for the breast removed fromthe preventive mastectomy to have immediate reconstruction, avoidingunnecessary scarring in this breast.

In one embodiment, a prosthesis may be inserted into the breast cavityof a breast removed for preventive measures. Similar to the step 104 inFIGS. 1 and 2 or step 304 of FIG. 3, the prosthesis may be inflated to avolume such that the 3-D shape and landmarks of the breast aremaintained. If a patient does not require post-mastectomy treatment inthe breast with abnormal cells, both breasts may be prepared fordefinitive reconstruction.

If a patient requires a post-mastectomy treatment, such as radiation inthe breast cavity with abnormal cells, the prosthesis in the breastremoved for preventive measures may remain inflated. Alternatively, theprosthesis in the breast removed for preventive measures may be deflated(similar to step 110 of FIG. 1 or step 306 of FIG. 3) during theduration of the post-mastectomy radiation. In this embodiment, after thepost-mastectomy radiation, the prosthesis may be reinflated, similar tostep 114 of FIG. 1 or step 310 of FIG. 3. The prosthesis may bereinflated in a gradual manner, where a predetermined amount of fluidmay be inserted into the prosthesis at a predetermined interval. Theinsertion process may continue until the prosthesis attains a volumesimilar to or substantially equal to the volume achieved after themastectomy and prior to the deflation step. Alternatively, theprosthesis may be inflated by adding, in one step, a fluid such that thevolume of the prosthesis is to or substantially equal to the volumeachieved after the mastectomy and prior to the deflation.

In other embodiments, patients who have a higher risk of getting breastcancer due to, for example, genetics, the removal of both breasts mayreduce chances of occurrences. In one embodiment, a prosthesis may beinserted into each breast cavity after the mastectomy and inflated tomaintain the shape and landmarks of breast skin envelope. The methodallows for pathology analysis of the tissue sample to be determinedbefore a definitive strategy for breast reconstruction to be decided.

Breast Skin Preserving Prosthesis

The prosthesis referred to in the flowcharts of FIGS. 1 through 4, is abreast preserving prosthesis that may preserve the shape, form,dimensions, and natural landmarks of the breast skin envelope after askin-sparing mastectomy. The use of the prosthesis to prepare the breastarea may aid in obtaining a more natural, aesthetically pleasing outcomeafter breast reconstruction surgery.

Additionally, the prosthesis may maintain its structural integrityduring an irradiation process and may also not interfere withpost-operative therapy. For example, the prosthesis may be manufacturedfrom materials that would not deflect radiation beams. The prosthesismay also be manufactured in such a way that the materials would notdegrade from the exposure to the radiation beams and will allowinstillation of a radioactive material to treat surrounding tissues.

For example, referring to FIGS. 5A and 5B, an external beam prosthesis(500A) and a brachytherapy prosthesis (500B) is shown, respectively, maybe inserted into a breast cavity after a mastectomy, and may be inflatedto a volume that may preserve the 3-D shape, form, and landmarks of thebreast. In one embodiment, the volume of prosthesis 500A or 500B may bean amount such that the breast is similar to or substantially equal tothe shape and size of the breast prior to the mastectomy. Alternatively,the volume may be an amount such that the breast is smaller or largerthan the breast prior to the mastectomy. External beam prosthesis 500Aand brachytherapy prosthesis 500B are discussed in further detailsbelow.

In one embodiment, prosthesis 500A or 500B may be inserted into a breastcavity and placed underneath the pectoralis major muscle 602 in adeflated state and on the chest wall 604, as shown in FIG. 6A (a crosssection of prosthesis 500A or 500B on a chest wall). Prosthesis 500A or500B may include base structure 502 coupled to balloon 504. In oneembodiment, prosthesis 500A or 500B may comprise an outer shell that maybe soft, yet durable. The flexible nature of the prosthesis avoidscausing injury to the chest wall 604 and/or the breast skin duringinsertion, inflation, or reinflation, and during radiation. In otherembodiments, prosthesis 500A or 500B may also be manufactured frommaterials that may allow optimal penetration of radiation beams, whileavoiding divergence of the beam fields that may result in aninhomogeneous dose distribution.

In addition, prosthesis 500A or 500B may be made of a material that maymaintain its structural integrity throughout the various steps (e.g.,steps shown in FIGS. 1, 2, 3, and 4). For example, prosthesis 500A or500B may be made of materials that may not breakdown into differentbyproducts that may lead to structural degradation.

When deflated, balloon 504 lies on base structure 502. The profile ofballoon 504 does not include cupped edges and therefore, may notinterfere with any potential post-mastectomy radiation treatments anddoes not injure the overlying skin, i.e., the prosthesis 500A or 500Bdoes not protrude or is exposed through the skin. Additionally, basestructure 502, may include a stable and spring-like framework and may beextended in an upright manner to reduce or substantially eliminatepressure on the chest wall 604 when balloon 504 is in an inflated state,preventing an indention in the chest wall 604 of the patient.

In one embodiment, when the prosthesis is deflated, for example, priorto radiation, the flexible, spring-like framework of base 502 may allowthe prosthesis to maintain its structural integrity over contractileforces from radiation beams, as shown in FIG. 6A. Therefore, if theprosthesis was reinflated after the radiation therapy, the prosthesismay allow for optimal re-inflation, i.e., maintain the shape and volumeof the breast prior to deflation.

In other embodiments, when the prosthesis is deflated, base 502 andballoon 504 may contour to the anterior chest wall, thus avoidingelevated and irregular edges. The profile of balloon 504 in the deflatedstate may not interfere with radiation delivery. Additionally, in thedeflated state, the prosthesis does not sink or settle into the chestwell 604, and thus, reduces or substantially eliminates the risk ofcreating a concavity in the chest wall 604.

When the prosthesis is inflated or reinflated (e.g., step 104 of FIGS. 1and 2, step 304 of FIGS. 3 and 4, step 114 of FIG. 1, or step 310 ofFIG. 3), balloon 504 may be injected with a fluid such as, but notlimited to, saline, water, distilled water and the like. Alternatively,any biocompatible material may be used to inflate balloon 504. As a nonlimiting example, biocompatible materials such as hydrogel, collagen,fibrin, elastin, or the like may be injected into balloon 504. In otherembodiments, balloon 504 may be injected with air. Alternatively,balloon 504 may be filled with a liquid, gaseous, or other suitableradioactive materials used for treatment of the breast cavity. Theinsertion of the radioactive material may accelerate breast irradiation.

In one embodiment when the prosthesis is inflated, the shape of balloon504 and the base structure 502 may attain a more natural, ptotic shapebreast skin envelope. The preservation of the breast skin is thisconfiguration allows for a more aesthetically pleasing outcome when adefinitive breast reconstruction is performed.

Additionally, as balloon 504 inflates, base structure 502 flattens toabsorb the pressure due to the inflation process. The absorption of thepressure may help maintain a substantially flat chest wall, which mayprovide a more natural looking breast during reconstruction. The basestructure 502 has built-in resistance to equalize posterior force ofexpansion on breast tissue to avoid deformation of the chest wall. Forexample, the negative resistance provided by base structure 502 againstthe pressure of the inflated balloon may avoid a concave deformity ofthe chest wall and ribs, as shown in FIG. 6C. A depression 606 into thechest wall may result during expansion when using currently-availabletissue expanders. The avoidance of the concavity can decrease the needto supply additional soft-tissues to fill the concavity, leavingadequate tissue to reconstruct the breast as well as a contralateralbreast if required. Alternatively, the avoidance of the concavity mayleave a substantial amount of tissue to reconstruct the breast to besymmetric to a contralateral breast.

Types of Prosthesis

Each patient undergoing a mastectomy may present different physicalcharacteristics, and as such, the prosthesis selected may need to becustomized. For example, circumstances including, without limitation,the size of the breast, the shape of the breast, the size of thepatient, and/or the advancement of the cancer cells in the breast, mayneed to be considered prior to a mastectomy. As such, according to oneembodiment, a prosthesis used in the delayed-immediate, delayed-delayed,or preventive mastectomy methods may be customizable for each patient.

In one embodiment, the prosthesis may be side specific prosthesis (i.e.,right-breast prosthesis and left-breast prosthesis). In otherembodiments, the prosthesis may come in various sizes to accommodatedifferent breast volume. Prior to the step of performing a mastectomy, aproper prosthesis may be determined, including, for example, determininga side-specific prosthesis and/or measuring the width of a chest wallfor determining the appropriate size of the prosthesis.

In other embodiments, prosthesis 500A or 500B may include variousanterior projection profiles (the projection of the breast from thechest wall), depending on the reconstructive needs and the desires of apatient. In one embodiment, the chest wall may be measured and a sizeand shape of a prosthesis may be selected based on the size. The sizeand shape may vary depending on the desired aesthetic outcome ormatching of a contralateral breast.

In addition to the above, for patients who are at risk forpost-mastectomy treatment or for patients who are required to undergopost-mastectomy treatment, a prosthesis, appropriate for the type oftreatment, may be chosen. In one embodiment, for patients who are at alow-risk of requiring post-mastectomy treatment or for those whosetreatment includes external beam irradiation, an external beamirradiation prosthesis may be used. Alternatively, for patients who mayneed an internal beam irradiation or an internal and external beamirradiation combination, a brachytherapy prosthesis may be used. Detailsof the external and internal beam irradiation prostheses are presentedbelow.

External Beam Irradiation Prosthesis

Referring to FIG. 7, an anterior view of a vertical cross section ofexternal beam irradiation prosthesis 700 is shown. Prosthesis 700 may besimilar to prosthesis 500A shown in FIG. 5A. Prosthesis 700 includesbase structure 702 and a balloon coupled to base structure 702 (for thesake of brevity, the balloon is not shown). The base structure 702 maycomprise a framework that allows for separate angulations for eachsection to contour to the chest wall, as shown in FIG. 7. Prosthesis mayalso include a breast and breast and axillary drainage tube 706,including an axillary extension 707, coupled to axillary drainage port708 (shown in FIG. 5A) for draining bodily fluids,instillation/evacuation tube 710 coupled to instillation/evacuation port712 (shown in FIG. 5B) for inflating and deflating a balloon coupled tobase structure 702. Prosthesis 700 may also include suture secure tabs714 for attaching prosthesis 700 onto a chest wall, reducing orsubstantially eliminating post-mastectomy displacement of theprosthesis.

In one embodiment, breast and axillary drainage tube 706 may beintegrated into the perimeter of prosthesis 700, as seen in FIG. 7,FIGS. 8A and 8B, and FIG. 9. FIG. 8A shows a side view of inflatedprosthesis 700 that include breast and axillary drainage tube 706 at theperimeter. The flexible base structure 702 may move down based onpressure from inflation of the balloon 704. FIG. 8B illustrates across-section of breast and axillary drainage tube 706, which mayinclude a fenestrated peripheral drain (e.g., fenestrated peripheraldrainage system 709) with central open core for passage of devices, suchas an unclogger, i.e., breast and axillary drainage tube 706 may includeopenings which may draw fluid build-up in the breast cavity (a close-upview of breast and axillary drainage tube 706 is shown in FIG. 9). Thefenestrated peripheral drain may also comprise a double-perforated corewith off-setting perforations. In one embodiment, breast and axillarydrainage tube 706 may be seated into base structure 702 where the basestructure may be made of a flexible, plastic material. It is noted thatbase structure 702 may be made of other suitable materials known in theart. The drainage tube 706 may drain through a collar at a support strutas shown. FIG. 8C shows another view of the installation/evacuation tube710 connected to a port.

One distal end of breast and axillary drainage port 706 may extend to anaxillary part of the body, i.e., below the underarm. Here, breast andaxillary drainage tube 706 may be coupled with axillary drainage port708, which may be placed underneath the skin (as shown in FIG. 7 andFIG. 9). In one embodiment, port 708 may be a metal port. Alternatively,port 708 may include a biocompatible material. Due to the placement ofport 708 (e.g., on the lateral wall as shown in FIG. 5A), port 708 maybe outside of the field of radiation, therefore, does not deflectradiation beams.

Breast and axillary drainage tube 706 and axillary drainage port 708,(collectively, the drainage system) may allow for readily accessibleexternal drainage of fluid build up, including, without limitation,seroma fluids in the breast cavity. The drainage system avoids the needfor an external drain in contact with the prosthesis, which may decreasethe risk of infection. In addition, the evacuation of the accumulatedfluids avoids the need for an expensive, risky surgical drainage toremove the fluids. The removal of the accumulated fluids will bediscussed in further detail with respect to the needle-locking techniqueof the external beam prosthesis.

Similar to breast and axillary drainage tube 706,instillation/evacuation tube 710 may be integrated to base structure702. Instillation/evacuation tube 710 may have one distal end coupled toballoon 704 for inflation or deflation purposes. In other embodiments,instillation/evacuation tube 710 may be independent of base structure702. For example, one distal end of instillation/evacuation tube 710 maybe provided through the center of base structure of 702 (as seen in FIG.7) and may protrude from the top of base structure 702 into balloon 704,as shown in FIG. 8A. This may allow for the direct inflation of balloon704 via instillation/evacuation tube 710. Similarly, balloon 704 may bedeflated via instillation/evacuation tube 710. The other distal end ofinstillation/evacuation tube 710 may coupled to instillation/evacuationport 712. In one embodiment, port 712 may be a metal port.Alternatively, port 712 may be made of a biocompatible material. Due tothe placement of port 712 (e.g., on the lateral chest wall as shown inFIG. 5A), port 712 may be outside of the field of radiation, therefore,does not affect radiation treatments that may be administered.

When a patient undergoes a mastectomy, and during the waiting period forpathology test results and/or the recovery time from the mastectomy,prosthesis 700 may be inserted into the breast cavity to preserve thebreast skin envelope and other landmarks of the breast. In oneembodiment, using instillation/evacuation tube 710 andinstillation/evacuation port 712 (collectively, theinstillation/evacuation system), a fluid may be injected through port712 and may travel through tube 710 to balloon 704, inflating theprosthesis. Similarly, if a patient requires a post-mastectomy radiationtreatment, the instillation/evacuation system may be used to draw thefluid from balloon 704, leaving a deflated prosthesis. For example,referring to FIG. 17, a rapid fluid instillation/evacuation device isshown. Using a needle-locking technique (discussed below), a needle,coupled to a manual valve, may be inserted into port 712. Port 712 maybe configured in different geometries such as a drum port and the like,as would be recognized by one of ordinary skill in the art. The valvemay be switch to a first position, allowing for a rapid instillation ofa fluid, such as, but not limited to, saline, water, other liquids, air,soluble gases, liquid radiation material or other radioactive materialthrough tube 710 into balloon 704. Similarly, if the prosthesis needs tobe deflated, the valve may be switched to a second position, allowingfor a rapid of the fluids from the balloon into a collection bag.

It is noted that prosthesis 700 may also be inflated, for example, byproviding air or biocompatible material through theinstillation/evacuation system into balloon 704. The injecting thefluids, air, and/or biocompatible material will be discussed in furtherdetailed with respect to the needle-locking techniques of the externalbeam prosthesis.

Needle-Locking Techniques

In one embodiment, ports 708 and 712 may each be respectively accessedvia a needle-locking method, as shown in FIGS. 10A and 10B. A needle,similar to needle 752A, 752B, or 752C (collectively needle 752) of FIG.10B, which may be specific to port 708 or 712, may be used to remove andcollect the fluid. For example, needle 752 may be specific to drainageport 708, and may be coupled to a suction bulb that provides a negativepressure that draws the liquid through the openings of breast andaxillary drainage tube 706 through port 708 into a collection bag, asshown in FIG. 14B. Suction bulb 1402 may be worn around the abdomen viaan abdomen strap and may lay substantially flat against the abdomen. Inaccordance with various embodiments, needle 752 is flush with the chestwall and can remain in-situ for drainage during perioperative period.The needle 752 may be re-inserted as required and may be coated with asoft rubber coating to avoid skin irritation. FIG. 14B further shows aspecific locking configuration for a saline insertion/removal two wayvalve 1402 and a seroma fluid removal valve 1404. Still further, FIG.14B shows a side view of ports 708 and 712 with suture fixation points1406 and a skin view of ports 708 and 712 with plastic leaflets 760. Amechanism of needle attachments 1408 is further shown, where apractitioner may penetrate the port 708, 712, and then turn and/or pullthe needle 752 to lock the needle 752 in place. In some embodiments, theneedles 752 are flush with the chest wall.

In other embodiments, needle 752 may be coupled to a battery operatedfluid evacuator 1500 which may apply an appropriate negative pressure todraw out the fluids, as shown in FIG. 15. Particularly, the batteryoperated fluid evacuator may provide a vacuum pressure via a motor 1504for pulling the fluids through drainage tube 706, through port 708,through a needle (similar to needle 752 of FIG. 10B), and into adrainage collection bag 1502. As shown in FIG. 15, the fluid evacuator1500 comprises a male-female connection 1506 for a needle-lockingsystem.

Alternatively, in other embodiments, needle 752 may be coupled to agravitational drainage bag that may be worn on the legs of the patient,as shown in FIG. 14A. The gravitational drainage bag may draw the fluidfrom inside the breast cavity through drainage tube 706, port 708, andto a collection bag worn on a patient's leg. The above embodiments(shown in FIGS. 14A-14B and FIG. 15) allows for body fluids to beremoved in a more efficient manner, reducing or eliminating infectionnormally caused from surgical implementations to remove the fluid.Additionally, the above methods allow a patient to remove theaccumulated fluids more frequently, further reducing complicationscaused by fluid-build up. In some embodiments, after the postoperativeperiod, the above methods may be used to drain the inadvertentcollection of fluids in the breast or axillary regions.

In one embodiment, needle 752 may include an appropriate latch that maybe used to connect to port 708 from above the skin. As shown in FIG.10A, port 708 may include locking tabs 754, which allows only one latchconfiguration of a needle 752 to connect to the port 708 and avoidsinadvertent removal of the needle 752 during draining, inflating, and/ordeflating steps, and during activities of daily living. Additionally,the needle locking technique eliminates any erroneous access to theprosthesis such as, but not limited to, accidentally deflating theprosthesis when the body fluids needs to be drained, etc. In anon-limiting example, needle 752 may include latches, such as, but notlimited to, a male-female connection of different geometries as seen inFIG. 10B. As such, port 708 may be customized to include locking tabs754 of different geometry to accommodate the needle 752. The differentneedle locks may allow for distinguishing between the different portslocated in the similar area. For example, instillation/evacuation port712, which may be used to inflate and/or deflate the prosthesis, may belocated in the general vicinity of drainage port 708. If the prosthesismay need to be deflated, a needle designed for port 712 may be used toaccess port 712 to draw the fluid from the balloon of the prosthesis. Toensure that port 712 is being accessed, as opposed to drainage port 708,the needle must lock into port 712 prior to the removal of any fluids.FIG. 10A shows the drainage port 708 positioned under the skin 1004,comprising plastic leaflets 760, and coupled to tubing 1002 that leadsto the prosthesis. As shown in FIGS. 10A and 10B, the needle 752 mayconnect to a collection system via tubing 1006 to a bulb or leg bag (notshown).

In one embodiment, referring to FIG. 5A and FIG. 11B, port 708 and 712may be housed as a single structure 1150, termed dual-port system, andmay be positioned horizontally on the lateral chest wall and may have aplurality of tubes connecting to the prosthesis' tube, such as drainagetube 706 and instillation/evacuation tube 710. In one embodiment, tubes706 and 710 may have a larger diameter than the plurality of tubes fromthe port. This may allow for unobstructed passages of devices from theports into the prosthesis, like insertion of radiation rods or acleaning device.

In one embodiment, having the ports housed as a single structure, allowsfor the tubes 706, 710 connected to the prosthesis to be easilymaneuvered to the lateral chest wall through a suction tunnelingtechnique, as shown in FIG. 16. In one embodiment, suction tunneler 1600may be for passage of the tubing of the prosthesis to the ports locatedon the lateral chest wall, including, without limitation, drainage tube706 and instillation/evacuation tube 710 via, for example, a screw tip1604 used for penetrating through the subcutaneous tissues. A suctionpump 1606 coupled to a suction attachment 1602 of suctioner 1600 mayprovide a negative vacuum pressure, drawing the tubes from theprosthesis to the chest lateral wall. An additional benefit of havingthe dual port system is the customization of the tubes connected to theport. Depending on the size of the chest wall, the tubes (e.g., drainagetube 706 and instillation/evacuation tube 710) may be trimmed to fit apatient. Furthermore, passage of the tubes through narrow tunnels canhelp eliminate healing problems in this region for patients who requireradiation therapy.

In other embodiments, the ports 708 and 712 may be housed as a singlestructure situated horizontally on the inferior and lateral aspect ofthe chest wall. The locations of the ports, which may be made of metalor other biocompatible material, may be outside a radiation field, andthus, may not interfere with the post-mastectomy therapy. Alternatively,ports 708 and 712 and the prosthesis may be a single, integral unit.

Generally, if there is an accumulation of fluids in a chamber of theports, the overlaying skin can break down and expose the port. As such,in one embodiment, referring again to FIG. 10A, port 708 (and similarly,instillation/evacuation port 712), may be centrally depressed or concavefrom the skin level. This shape may allow the overlying skin to healafter the removal of the needle. Further, to reduce agitation to theskin, needle 752, may include a soft, sponge-like material to protectthe skin from irritation. Additionally, ports 708 and 712 may alsoinclude four leaflets 1202, as shown in FIG. 12, which are similar tothe leaflets 760 described above. The four mechanical (e.g.,spring-loaded) leaflets may turn inward when a needle is insertedthrough the skin, reducing or substantially eliminating any fluidaccumulation in the concavity of the port when the needle is removed.This allows the skin to heal adequately after removal of a needle. Oneof ordinary skill in the art would recognize that other geometries asidefrom the four leaflets may be suitable for reducing or eliminating anyfluid accumulation in the port.

The needle-locking components and techniques described in the presentdisclosure are not limited to the application described. Theneedle-locking components and techniques may be used for other medicalapplications and/or with other medical devices known in the art.

Similarly, the components shown, for example, in FIGS. 9, 13A, 13B, 14A,14B, 15, 16, and 17 are not limited to the techniques described in thepresent invention. One of ordinary skill in the art would recognizetheir use in the medical field in other applications as well as incombination with other medical devices and techniques.

Brachytherapy Irradiation Prosthesis

As noted above, survival advantages with post-mastectomy treatment occurwhen internal mammary nodes are treated within the radiation fields. Thepresent disclosure provides for the treatment of these internal mammarynodes, as well as the chest wall and axillary lymph nodal basins, byproviding a prosthesis adapted to receive a plurality of brachycatheterrods. In one embodiment, the brachycatheter rods may administer theradiation field to treat the breast cavity internally. In otherembodiments, the brachycatheter rods may be used to treat the breastcavity internally while an external beam may be used to treat the breastskin and clavicular nodes. These treatments may be done while theprosthesis is still inflated. Alternatively, these treatments may bedone with the prosthesis deflated.

In one embodiment, referring to FIG. 18, brachytherapy irradiationprosthesis 1800 is shown. Brachytherapy irradiation prosthesis 1800 maybe similar to prosthesis 500A, 500B, and 700 of FIGS. 5A, 5B, and 7,respectively, and may also include, for example, a plurality ofbrachytherapy sleeves built into the base structure. The sleeves,coupled to brachytherapy port 1810 (shown in FIG. 5B), may providetracks for receiving a radioactive source (e.g., radiation rods liquidradiation source, gaseous radiation source, wire placement with anradioisotope attached to the wire, etc.). The sleeves may also positionbrachycatheter rods proportioned on the chest wall below the elevatedframework of the prosthesis 1800 and axillary region for providingoptimal treatment to patient. The framework allows for separateangulations for each section to contour to the chest wall. The frameworkmay be stabilized by using axillary suture tacking 1850 at sidebarconnectors 1852.

In some respect, the brachytherapy port 1810 may be integrated into theprosthesis as an integral unit. The brachytherapy port 1810 may beintegrated underneath, to the side, or spaced apart from the prosthesis.

In one embodiment, the brachycatheter rods may be customized to acertain length and diameter to fit a prosthesis appropriate for thepatient, i.e., the rods may need to be customized based on the breastsize of the patient, the chest wall size of the patient, the side of thebreast needing treatment, etc. Additionally, the brachycatheter rods mayhave different radiation emission widths depending on the location ofthe rod in the prosthesis, e.g., the axillary region or the chest wall,and thus can extend treatment to different areas in the chest cavity.

Brachytherapy irradiation prosthesis 1800 may also include a drainagesystem (breast and axillary drainage tube 706 and drainage port 708) forremoving bodily fluid collected in the breast cavity and axillaryregion. Additionally, prosthesis 1800 may include aninstillation/evacuation system (instillation/evacuation tube 710 andinstillation/evacuation port 712) for inflating and deflating a balloon(not shown) coupled to base structure 1802. In order to secureprosthesis 1800 onto the chest wall of a patient, a plurality of suturetabs 714 coupled to base structure 1802 may be provided. The suture tabs714 may be oriented in various positions about the prosthesis. Theprosthesis 1800 additionally may include intracatheter connectors 1854.

Referring again to FIG. 11A, the brachycatheter port may be housed as asingle structure with drainage port 708 and instillation/evacuation port712 (collectively called the three-port system). In one embodiment, abrachycatheter radiation rod may be inserted into a prosthesis via abrachytherapy port and a needle-locking mechanism. For example,depending on the location of the tracks and the brachycatheter rodsneeded at that location, the size and length of the brachycatheter rodsmay vary. As such, the brachycatheter port may be a multi-channel portto accommodate the various brachycatheter rods. In one embodiment, abrachycatheter rod may be threaded through the brachycatheter port by aneedle-locking technique, where one type of brachycatheter rods may fitinto one channel of the multi-channel brachycatheter port. For example,referring to FIG. 12, a port coupled to a connection tube 1204 is shown.The port may be a brachycatheter port. Alternatively, the port shown maybe a drainage port (similar to port 708) or an instillation/evacuationport (similar to port 712). The port of FIG. 12 may include a lockingsystem that allows only one input to connect to that port. As such, ifthe port of FIG. 12 is a brachycatheter port, the locking system mayallow only brachycatheter rods to be inserted, thereby eliminatingsurgical routines to insert the brachycatheter rods which can cause arisk of infection, scarring, and considerable expenses to the patient.The connection tube 1204 may connect to tunneled tubing 1206 from theprosthesis to enable passage of radiation rods and/or a drain unclogger.

Alternatively, in order to determine the location for the differentbrachycatheter rods, particularly brachycatheter rods of differentlengths and/or different radiation emission widths, each sleeve may becolor coded and the similar color may be reflected in port 1810.Referring to FIG. 11A, using a needle-locking technique similar to thetechnique described above, a needle may be inserted and locked into port1810, exposing the color scheme of the port. Depending on the type ofrod, a doctor may thread the rod through the track into the prosthesis.

Embodiments Common to the External Beam Irradiation Prosthesis and theBrachytherapy Irradiation Prosthesis

In one embodiment, the needle locking technique described above may alsoinclude unclogger 1000 coupled to port 708 and/or port 712 to prevent orremove debris from remaining in the prosthesis and obstructing flow, asseen in FIGS. 13A and 13B. Unclogger 1000 may include a syringe 1002having a plunger end 1001 and an inflatable balloon tip 1004. Referringto FIG. 13A, balloon tip 1004 may be deflated prior to inserting into aport, such as, but not limited to a drainage port or aninstillation/evacuation port. Referring to FIG. 13B, using a latchappropriate for the security tabs of each port, the balloon 1004 may beinserted via a port into a tube. FIG. 13B shows a needle inserted into adrainage system port. Syringe 1002 may include some fluid and may beused to inflate balloon tip 1004 by depressing the plunger 1001. Balloontip 1004 may be routed through the tubes and may clear any debrispresent in the tubes of the prosthesis. For example, balloon tip 1004may be used to clear matter within the core of the drainage tube 706 ofFIG. 7. Similarly, balloon tip 1004 may be used clear debris (e.g.,matter build-up) from instillation/evacuation tube 710 of FIG. 7.

Radiation Brassiere

In one respect, a radiation brassiere, as shown in FIGS. 19-23, may beused in combination with the above prosthesis or separately to deliverradiation to the, for example, the skin of the breast, chest wall, andaxilla, as well as regions of the chest wall, and regional nodal basins(e.g., axillary, internal mammary, infraclavicular, and supraclavicularnodes). In some embodiments, the radiation brassiere may be specificallydesigned to be used after patients having a total mastectomy or forpatients undergoing partial mastectomies. The radiation brassiere mayalso be used alone or in combination with other treatment (e.g.,external beam irradiation, chemotherapy, etc.) as determined by aradiation oncologist. In one embodiment, the radiation may be deliveredin a hospital based setting where patients may be able to receive theirradiation treatment as an outpatient. Alternatively, the radiation maybe delivered in any other environment as suited for the patient.

In one embodiment, radiation brassiere 1900, which may be similar to abody suit, may extend from the neck to the umbilicus, as shown in FIG.19A. The brassiere 1900 may be made of an elastic band material whichconforms to the body and prevents migration and movements duringtreatment. One of ordinary skill in the art would recognize that othersuitable materials may be used instead of or in addition to the elasticband material. The radiation treatment brassiere may be side specific(right or left breast) or may be bilateral model for patients in need ofradiation treatment deliver to both breasts.

The brassiere may have a separator ring 1902 surrounding a non-affectedbreast to push the breast away (laterally) from the external region,typically used for patients needing treatment on one breast. In somerespect, brassiere 1900 may be a single unit design, but may haveseveral paneled treatment zones to customize treatment to specificregions of the breast, chest wall, and nodal basins based on thepatients pathology and need for individualized treatment.

In some respects, the radiation brassiere may include brachytherapyradiation sheaths that may be color-coded by zones and may built intothe radiation treatment panels with openings strategically placed foreasy access to allow for insertion of radiation rods. For example,Velcro flap covers 1910 may be present at radiation rod insertion sites1904 to cover the slots of the inserted rods to avoid inadvertentremoval during activities of daily living. Each rod insertion site 1904may be labeled to match each specific rod length. One of ordinary skillin the art would recognize that other materials may be used to cover andsecure the slots of the inserted rods including, without limitation,pins, snaps, fasteners, zippers, and the like. In some respect, each rodinsertion slot 1904 may be labeled to match each specific lengthradiation rod. Further, the radiation panels in the regions fortreatment may be thicker than the remainder of the brassiere, which maybe a sheer elastic material available in various colors (i.e., black,nude, or white).

In one embodiment, the radiation brassiere may include multiple areas oftreatment, as shown in FIG. 19B. For example, the areas of treatment mayinclude, without limitation, a superior breast skin area, includingunderlying pectoralis major muscle (Zone 1), an inferior breast skinarea (Zone 2), an axilla skin area, including underlying axillary lymphnodes (Zone 3), an inferior chest wall skin (Zone 4), an external skinarea, including the internal mammary lymph nodes (Zone 5), a superiorchest wall skin area, including infraclavicular lymph nodes (Zone 6),and the supraclavicular lymph nodes area (Zone 7). Each radiationtreatment zone may be customized for each patient's need based on, forexample, the treatment regimen and the depth of penetration of theradiation emission. The zones depicted here are exemplary and one ofordinary skill in the art would recognize that other divisions may besuitable, i.e., a plurality of zones may be combined, not used, or theremay be one zone for the entire chest area.

Referring to FIGS. 20A through 20D, cross-sectional diagrams ofradiation brassiere 2000 are shown. In one respect, radiation brassiere2000 shown in FIG. 20A may be used for the treatment of the breast skin,subcutaneous tissues, and the chest wall areas (Zone 4). Similarly,radiation brassiere 2000 of FIG. 20C may be used to treat the breastskin, subcutaneous tissues, and the chest wall areas as well as nodalbasin areas (e.g., Zones 3, 5, 6, and 7). In FIG. 20B, radiationbrassiere 2000 may be used to treat the breast skin, subcutaneoustissues, and the pectorialis muscle (Zone 1). The radiation brassiereshown in FIG. 20D may be used for the treatment of breast skin andsubcutaneous tissues areas (Zone 2).

Each of the radiation brassieres shown in FIGS. 20A through 20D mayinclude radiation treatment panels 2000 that include outer radiationshield 2002 to prevent exposure to other anatomic regions of the patient(i.e., extremities) and others who come in contact with the patient. Inone respect, the radiation shield layer 2002 may also shield theradiation that is delivered via a brachytherapy prosthesis modeldisclosed above. See FIG. 21.

The radiation treatment panels may also include radiation rod sleevesthat may be surrounded by radiation beam direction reflector plate 2004to angle the beams only towards the patient. The radiation rod sleevesmay be positioned within buffer layer 2006 that may allow for asubstantially even distribute the radiation beams to the treatmentregions.

The radiation treatment panels may also include an adhesive layer usedto adhere the radiation treatment panels to the skin. In one respect,the adhesive layer may allow for an even distribution of radiation atpredetermined penetration depths to the areas needed treatment. Theadhesive layer may also stabilize the radiation treatment panels to apatient to prevent shifting or movement during a treatment as well asprevent erroneous delivering of radiation to unaffected areas.

The layers depicted in FIGS. 20A through 20D are example layers. One ofordinary skill in the art would recognize that layers 2002, 2004, 2006,and 2008 may be configured in any order and may include otherinterposable layers.

The brassiere sizing (dimensions) may coincide with an underlyingimplanted prosthesis similar to the prosthesis shown in, for example,FIGS. 5, 7, and 18. As mentioned previously, the radiation rods can havevarious emission widths and may be customized based on the treatmentplan. In one respect, an opening in the brassiere may be providedallowing for access to subcutaneous port 2222 of the implantedprosthesis (e.g., 2- or 3-port system) placed on the lateral chest wallat the time of mastectomy, as shown in FIG. 22. The implanted prosthesisplacement may allow for simultaneously treatment of the chest wallunderlying the balloon-like prosthesis and axillary and internal mammarynodal basins (brachytherapy rods sheaths built into the base structureof the prosthesis) and to treat the skin of the breast and chest wall,chest wall, and internal mammary, clavicular, and/or axillary nodalbasins using the radiation brassiere.

The use of a prosthesis and a radiation brassiere such as thosedisclosed in this disclosure may allow patients to better maintain theiractivities of daily living and work schedules. In one respect,approximately one week after surgery when the surgical pathology iscomplete, a patient may be fitted for a radiation brassiere (e.g.,measurements of the chest wall, determining if a single or bilateralbrassiere, radiation rod length, and the like). In one embodiment, apatient may be measured using infrared scanner 2352 with stick onindicators 2350 at various anatomic points, as shown in FIG. 23. Thescanner may take measurements that may be directly download via portconnection 2353 (e.g., a wired connection such as a USB connection or awireless connection) to computer 2356. The information may be uploadedto the Internet, and more particularly to the brassiere manufacturer.

Alternatively, the measurements of a patient may be done manually by adoctor and may be provided to the manufacturing device using forexample, the phone, internet, order forms and the like. Additionally,the measurements may take place prior to surgery, during surgery, orpost surgery. For example, the scanning may be performed postoperativelyafter a mastectomy and placement of a brachytherapy prosthesis 2360.

In some respect, the radiation rods, and in particular, the radiationemission widths from the brachytherapy rods and also for thebrachytherapy rods for insertion via the subcutaneous port into theimplanted prosthesis 2360 may also be provided to the manufacturer atthe same time the measurements for the customizable radiation brassiereor at an early or later time. The brassiere and rods for insertion intothe brassiere and/or the implanted prosthesis may subsequently be sentto a medical institution providing the radiation treatment. In onerespect, the radiation rods may be sent “hot” (activated with, forexample, Iridium or other radioactive material known in the art) or“cold” (non-activated) with activation at the treating medicalinstitution. In one embodiment, the rods may be inserted into thebrassiere by the manufacturer and then sent to the treating medicalinstitution or radiation oncologist. Alternatively, the rods may be sentseparate from the brassiere for assembly and/or activation at thetreatment facility.

Breast Reconstruction Kit

In one embodiment, breast reconstruction system may be package as a kit.The kit may include, without limitation: a breast prosthesis with abuilt-in drainage system, a suction tunneler for passing the pluralityof tubes from the prosthesis to the lateral chest wall to connect with aport, a device for applying negative pressure to draw fluids from thebreast cavity through the built-in drainage system. For example, the kitmay include battery operated seroma fluid evacuator with disposablefluid collection bags, a flat negative-suction bulb attachment forabdominal wear, or a gravity leg bag used to externally drain fluidsfrom the breast cavity through the built-in drainage system.

The kit may also include a syringe-loaded with balloon tip unclogger toremove any debris within the drainage system or any other tubes coupledto the breast prosthesis. The kit may also include ordering informationto obtain brachycatheter radiation rods to insert into sleeves of theprosthesis. Alternatively, the kit may include at least onebrachycatheter radiation rods (shielded for transportation and storage).

The kit may also include a rapid filler 1700, similar to FIG. 17 forinflating/deflating the prosthesis using a fluid. The rapid filler 1700may include a sterile saline instillation bag 1702 and a sterilevacuum-sealed saline evacuation bottle 1704. Additionally, a valve 1706is used for rapid saline filling of the prosthesis from the sterilesaline instillation bag 1702. The valve 1706 also allows for rapidremoval of saline from the prosthesis into the vacuum-sealed bottle 1704for sterile disposal. Alternatively, other devices may be included andmay be used to fill the prosthesis with other materials, including,without limitation, biocompatible materials, radioactive materials, air,soluble gases, and the like. Additionally, a plurality of lockingneedles may be provided in the kit. For example, a needle for accessingeach of the individual ports may be included.

Additionally, the kit may include schematic diagrams of the prosthesisand detailed approaches, similar to FIGS. 1-4 outlining how to use thebreast prosthesis to preserve the 3-D breast skin envelope and naturallandmarks of the breast. The detailed approach may include methods stepsfor patients with stage-I or stage-II breast cancer. The detailedapproach may include instructional steps for patients with stage-III orstage-IV breast cancer. Alternatively, the detailed approach may includeinstructions for patients who undergo preventive mastectomies.

The following examples are included to demonstrate specific embodimentsof this disclosure. It should be appreciated by those of ordinary skillin the art that the techniques disclosed in the examples that followrepresent techniques discovered by the inventors to function well in thepractice of the invention, and thus can be considered to constitutespecific modes for its practice. However, those of ordinary skill in theart should, in light of the present disclosure, appreciate that manychanges can be made in the specific embodiments which are disclosed andstill obtain a like or similar result without departing from the spiritand scope of the invention.

A possible clinical scenario in treating patients who needpostmastectomy radiation therapy may include placement of abrachytherapy model prosthesis at the time of mastectomy (shown in FIG.23). This may allow radiation delivery to be shortened considerably fromthe current six weeks of hospital based treatments with external beamirradiation for patients with breast cancer. For example, referring toFIG. 24, a patient may undergo a skin-preserving mastectomy. Abrachytherapy prosthesis may be inserted into the breast at the time ofthe mastectomy (step 2400). A four week time period may lapse where thepatient may recover from the mastectomy. At this time, the prosthesismay be inflated to preserve the breast skin and other natural landmarksof the breast. Upon healing from or as indicated by a treatment plan,the patient may undergo radiation treatment, where radiation rods may beinserted into the prosthesis, which may or may not be deflated (step2402). The radiation treatment may last about five days and the removalof the radiation rods may subsequently be removed (step 2406). Thepatient may subsequently be scheduled for a definitive breastreconstruction after a time period, usually about 6 weeks (step 2408).During the time between the treatment and the reconstruction surgery,the prosthesis may be reinflated either gradual or filled all at once toa volume substantially equal to or similar to the inflation volume priorto the radiation treatment.

In another clinical scenario where a patient requires a may or may notrequire post mastectomy radiation treatment, and in particular anexternal beam irradiation, the present disclosure provides the followingtechnique, as shown in FIG. 25. Steps 102, 106, and 108 are similar tothose described in FIGS. 1 and 2. If a patient does require radiationtreatment, in step 2509, a patient measured for a radiation brassiereeither manually or via the infrared scanning technique of the presentdisclosure. In particular, step 2509 allows for customization of thebrassiere as well as provides for designing of the radiation fieldappropriate for the patient (i.e., based on the pathology report).

Upon receiving the brassiere and activating the radiation rodsconfigured for the treatment, the patient may undergo radiationtreatment that lasts about 5 days (step 2511). One of ordinary skill inthe art can recognize that the time period disclosed here are examples.It is known that radiation treatment may vary for each patient andtherefore, the method may be adjusted accordingly.

After the radiation treatment, the radiation bra is removed and thepatient may subsequently be scheduled for a definitive breastreconstruction after a time period, usually about 6 weeks (step 2513).The total process last about 3 months as compared to the 2 years ofcurrent methods.

In some embodiments, the method shown in FIG. 25 may also include aprosthesis, such as a brachytherapy prosthesis. In optional step 104,the prosthesis may be inserted into the patient and inflated to a volumesufficient for preserving the breast skin envelope and other naturallandmarks of the breast. Upon determining if a patient requiresradiation treatment, and especially if a patient requires internalirradiation, in step 2509, the appropriate radiation field and lengthfor the prosthesis may also be measured and sent to a manufacture.

Prior to the administration of the radiation therapy, the prosthesis maybe deflated and the rods may be inserted via ports coupled to theprosthesis. After treatment (step 2511) and during the time between thetreatment and the reconstruction surgery, the prosthesis may bereinflated either gradual or filled all at once to a volumesubstantially equal to or similar to the inflation volume prior to theradiation treatment.

Other Applications for the Prosthesis

The above prosthetics have been discussed with respect to patients withbreast cancer who undergo mastectomy surgeries and have opted forreconstruction surgery. However, the prosthetics may be adaptable toother patient who desire breast reconstruction surgery. For example,patients with partial or total breast defects (e.g., breast conservationtherapy or lumpectomy with either partial or total breast radiationtherapy) who may undergo treatment (e.g., intraluminal into lumpectomydefect) may benefit from the prosthetics of the present disclosure whichmay shape and reconstruct tissue and skin in more natural manner.

Similarly, patients with no surgical defects may benefit from thetechniques and devices of the present disclosure. For example, carcinomain-situ patients (e.g., LCIS or DCIS), who generally do not requiresurgery, may need radiation treatment of the skin and some lymph nodesand in some embodiments, may need other treatment techniques such aschemotherapy. Using the radiation brassiere of the present disclosure,the patient may receive the external radiation treatment, which does notinterfere with other treatment regimens the patient may undergo.

With the benefit of the present disclosure, those having ordinary skillin the art will comprehend that techniques claimed here and describedabove may be modified and applied to a number of additional, differentapplications, achieving the same or a similar result. For example, anyinformation presented to a user can be presented in text and/or graphicformat. For example, one or more graphs, charts, clip-art, videos,animations, hierarchy trees, etc. may be used in addition to, or insteadof the text and numerical data shown in the figures and described here.The claims attached here cover all modifications that fall within thescope and spirit of this disclosure.

What is claimed is:
 1. A breast prosthesis comprising: a balloon; a portstructure that houses an instillation/evacuation port coupled to theballoon for inflating and deflating the balloon, wherein theinstillation/evacuation port comprises a locking system; and a suturesecure tab coupled to the balloon to couple the prosthesis onto a chestwall.
 2. The breast prosthesis of claim 1 further comprising a basecoupled to the balloon, wherein the base is configured to collapse whenthe balloon is inflated.
 3. The breast prosthesis of claim 1 furthercomprising a drainage system to remove fluids in a breast cavity.
 4. Thebreast prosthesis of claim 3 further comprising a fluid evacuatorcoupled to the drainage system to apply a negative pressure to draw afluid from the drainage system.
 5. The breast prosthesis of claim 1further comprising secure tabs for attaching the balloon onto a chestwall.
 6. The breast prosthesis of claim 1 further comprising a radiationport coupled to a radiation sleeve, the radiation port to accept aradioactive source for treatment of an internal breast cavity.
 7. Thebreast prosthesis of claim 1 wherein the port structure further housesat least one of a radiation port or a drainage port.
 8. The breastprosthesis of claim 7 wherein at least one of the radiation and drainageports of the port structure comprises a locking system.
 9. The breastprosthesis of claim 7 further comprising a rapid filler coupled to theinstillation/evacuation port to inflate or deflate the prosthesis usinga fluid.
 10. A device for administering an external brachytherapytreatment comprising: a plurality of treatment panels for receiving aradioactive source, the plurality of panels configured to treat aspecific region of a breast, chest wall, or nodal basin.
 11. The deviceof claim 10 further comprising a separator ring coupled to the pluralityof treatment panels for moving an affected breast away from thetreatment panels.
 12. A breast prosthesis comprising: a balloon; and aninstillation/evacuation port coupled to the balloon for inflating anddeflating the balloon; and a radiation port coupled to a radiationsleeve, the radiation port to accept a radioactive source for treatmentof an internal breast cavity.
 13. A method comprising: inserting apreserver into a breast; inflating the preserver to a volume forpreserving the breast skin envelope, the preserver comprising: a balloonto be inflated to a volume for preserving the breast skin envelope, aninstillation/evacuation port coupled to the balloon for inflating anddeflating the balloon, and a radiation port coupled to a radiationsleeve, the radiation port to accept a radioactive source for treatmentof an internal breast cavity; and performing a brachytherapy treatmentby providing a radioactive source to the radiation port.
 14. The methodof claim 13 further comprising removing fluids from the breast through adrainage system built in to the preserver.
 15. The method of claim 13further comprising performing a mastectomy on a breast and preserving abreast skin envelope prior to inserting the preserver into the breast.16. The method of claim 13 further comprising affixing the preserver toa chest wall with one or more suture secure tabs.
 17. The method ofclaim 13 further comprising deflating the preserver prior to performingthe therapy treatment.
 18. The method of claim 13 further comprisingperforming an external beam radiation treatment.
 19. The method of claim13 wherein providing a radioactive source comprises inserting at leastone radiation rod via the radiation port coupled to the preserver. 20.The method of claim 13 further comprising performing a brachytherapytherapy by providing a radiation brassiere.